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Completed Phase 3 Interventional Results available

LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

ClinicalTrials.gov ID: NCT01125566

Public ClinicalTrials.gov record NCT01125566. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jun 25, 2026, 12:02 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment

Study identification

NCT ID
NCT01125566
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Boehringer Ingelheim
Industry
Enrollment
508 participants

Conditions and interventions

Interventions

  • BIBW 2992 Drug
  • trastuzumab Drug
  • vinorelbine Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 21, 2010
Primary completion
Jun 7, 2013
Completion
Jul 5, 2018
Last update posted
Jul 17, 2019

2010 – 2018

United States locations

U.S. sites
14
U.S. states
9
U.S. cities
14
Facility City State ZIP Site status
Achieve Clinical Research, LLC Birmingham Alabama 35216
Ironwood Cancer and Research Centers Chandler Arizona 85224
Robert A. Moss MD, FACP, Inc Fountain Valley California 92708
St. Jude Heritage Healthcare Fullerton California 92835
University of California Los Angeles California 90095
Cancer Care Associates Medical Group, Inc Redondo Beach California 90277
Santa Barbara Hematology Oncology Medical Group, Inc Santa Barbara California 93105
Central Coast Medical Oncology Corporation Santa Maria California 93454
North Shore Cancer Research Associates Skokie Illinois 60076
Cedar Valley Cancer Center Waterloo Iowa 50701
Pro Health Care Associated Lake Success New York 11042
Hope Women's Cancer Center Asheville North Carolina 28806
Thomas Jefferson University Philadelphia Pennsylvania 19107
Utah Cancer Specialists Cancer Center Salt Lake City Utah 84106

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 193 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01125566, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 17, 2019 · Synced Jun 25, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01125566 live on ClinicalTrials.gov.

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